FDA
Susvimo now approved for diabetic macular edema
Brand name: Susvimo
Generic name: ranibizumab
Manufacturer: Genentech
Approval date: February 4, 2025
FDA approved Susvimo (ranibizumab injection), a vascular endothelial growth factor (VEGF) inhibitor, for the treatment of patients with diabetic macular edema (DME) who’ve previously responded to ≥2 intravitreal injections of a VEGF inhibitor. The drug is indicated for intravitreal use via the Susvimo implant.
Efficacy
Approval was based on data from the phase 3 Pagoda study (NCT04108156) involving 634 patients with DME who were randomized in a 3:2 ratio to receive continuous delivery of Susvimo via the implant q24wks or 0.5 mg intravitreal ranibizumab injections q4wks. Participants who received Susvimo refilled q24wks achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections (9.6 eye chart letters [similar to gaining two more lines on an eye chart] vs. 9.4 letters, respectively).
Safety
The most commonly reported adverse reactions (≥ 10%) were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract, and vitreous hemorrhage.
Recommended dose
The recommended dosage of Susvimo for DME is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the Susvimo implant with refills q24wks (approx. q6mo).
Sources:
FDA approves Genentech’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness. Genentech. 2025. https://www.gene.com/media/press-releases/15050/2025-02-04/fda-approves-genentechs-susvimo-as-the-f
Susvimo. Package insert. Genentech. 2025. https://www.gene.com/download/pdf/susvimo_prescribing.pdf